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BRIEF TITLE: A Randomized Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer

A Randomized Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer


  • Org Study ID: HSC20160162H
  • Secondary ID:
  • NCT ID: NCT02753309
  • NCT Alias:
  • Sponsor: The University of Texas Health Science Center at San Antonio - Other
  • Source: The University of Texas Health Science Center at San Antonio

Brief Summary

This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG.

Detailed Description


This study will evaluate change from baseline in gamma-delta T cell numbers and function and
Ag85 peptide-specific T cell responses following treatment.

Overal Status Start Date Phase Study Type
Recruiting Start Date: June 2016 Early Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Percentage change in systemic (whole blood) gamma-delta T cells frequency

Primary Outcome 1 - Time Frame: 4 weeks and 3 months after therapy

Primary Outcome 2 - Measure: Percentage change in systemic (whole blood) gamma-delta T cell proliferation in response to BCG-specific antigens

Primary Outcome 2 - Time Frame: 4 weeks and 3 months after therapy

Primary Outcome 3 - Measure: Percentage change in systemic (whole blood) Ag85 peptide-specific CD4 and CD8 T lymphocytes measured using human IFN-gamma release.

Primary Outcome 3 - Time Frame: 4 weeks and 3 months after therapy

Condition:

  • Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or
T1) bladder cancer

- In their treating physician's opinion is a good candidate for BCG therapy

- Be able to give informed consent

- Be age 18 or older

- Not be in an immunosuppressed state (e.g. HIV, use of chronic steroids)

- Not have active, uncontrolled infections

- Not be on agents known to alter rapamycin metabolism significantly

- Not have a reported history of liver disease (e.g. cirrhosis)

- Not have a prior history of non-bladder cancer unless the cancer is clinically stable
and not requiring active treatment except basal cell carcinoma or squamous cell
carcinoma of the skin.

- Not pregnant, or taking effective contraception before rapamycin therapy, during
therapy and for 12 weeks after discontinuation of therapy.

Exclusion Criteria:

- Have muscle-invasive (≥T2) bladder cancer

- Unable to give informed consent

- Age < 18

- Immunosuppressed state (e.g. HIV, use of chronic steroids)

- Active, uncontrolled infections

- On agents known to alter rapamycin metabolism significantly

- Another cancer requiring active treatment (except basal cell carcinoma or squamous
cell carcinoma of the skin)

- Patients at risk of pregnancy who are unwilling or unable to take effective
contraception before rapamycin therapy, during therapy, and for 12 weeks after
discontinuation of therapy.

- Individuals with a reported history of liver disease (e.g. cirrhosis)

- Individuals who are not a good candidate for BCG in their treating physician's opinion
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Robert Svatek, MD

Role: Principal Investigator

Affiliation: The University of Texas Health Science Center at San Antonio

Overall Contact

Name: Robert S. Svatek, MD, MSCI

Phone: 210-567-5676

Email:

Location

Facility Status Contact
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Recruiting Kerri Kendrick, MPAS
210-567-5676
kendrick@uthscsa.edu